Sean Ruane is a Materials Scientist and Supervisor in the Biotechnology and Pharmaceutical Services Division of RJ Lee Group. Sean has managed and conducted in-depth investigations of Foreign Particulate Matter (FPM) related to contamination identification, particle size and morphology analysis, and source determination. His expertise includes material characterization of materials using molecular spectroscopy (FTIR) for identification of organic components, as well as for the elemental composition of inorganic components utilizing high resolution electron microscopy (HR-SEM/EDS). Mr. Ruane also has extensive expertise in Immunophelometry, Chemistry Analyzers, Automated Analyzers (TECAN), TOC, Headspace Gas chromatography, RP-HPLC, ELISA, and chromogenic potency assays. He is a member of the American Association of Pharmaceutical Scientists (AAPS).
Custom chemical manufacturing companies who provide products used in the pharmaceutical, food, and cosmetics industries are all governed by the same cGMP, or current Good Manufacturing Practices, as the industry customers they serve. The Food and Drug Administration (FDA) established and regulates these guidelines, setting the standards for how a company manufactures its products and ensuring consumers receive goods that are consistent in quality, safety, and effectiveness.
Material identification and analysis are critical in the chemical industry, where foreign particulate matter (FPM) or other unknown substances can cause issues anywhere in the manufacturing process. Whether it be from damaged equipment, introduction of new equipment/process materials, or a formulation deviation, the identification of FPM is critical to keeping your product pure and unadulterated, so as to verify it will perform as intended in your customer’s final product.
News media has published countless stories of foreign matter in medications, food products, and cosmetics. Proper cGMP practices can safeguard public health, while also protect your company and your clients from public scrutiny, massive recalls, negative media attention, and even potential lawsuits. In recent years, thousands of pounds of food have been recalled due to FPM somewhere in the food production process, whether it was an object picked up during harvesting, introduced via the manufacturing equipment in process, or impregnated into the packaging. On an individual level, no one wants to bite into food and discover an unknown material; if you manufacture chemical additives or preservatives for food, your client requires the products they purchase to be safe and effective for public consumption.
One need only visit the FDA’s website on cosmetic recalls to see how many cosmetic products are found to be potentially harmful. Although many are recalled for undeclared ingredients, finding other items that have adulterated the product somewhere in their manufacturing process is simple. Past cases involved cosmetics containing mold growth, pieces of metal and plastic, mercury, lead, and even formaldehyde. Prescription drugs and medications, food products, and cosmetic/skincare products are items that humans ingest, inhale or inject every day. The consequences resulting from inadequate cGMP procedures can lead to short- or long-term effects on the consumer, making cGMP crucial to the health and well-being of the general public.
Material identifications are also important to manufacturers of pharmaceutical chemicals, as the quality of a product is only as good as the manufacturing process and the purity of the materials used. Each component used in a drug’s development, delivery and formulation lifecycle is likely to have its own inherent manufacturing process, and an effective cGMP lab can help provide quality inspection control services to each of these levels of involvement.
Quality control work is also an important aspect of the process for custom chemical manufacturing companies that provide pharmaceutical products (API’s), chemical food additives, and cosmetic ingredients because their customers utilize programs that are proactive rather than reactive. This quality by design approach allows their company to achieve quicker resolution to both large and small scale deviations by mitigating the burden for post-problem investigational work. And while many modern companies have their own quality control or quality assurance laboratories and inspectors, a third-party laboratory can provide product quality analysis that is not only objective, but will save your company valuable time. Many companies have found that their customers request third-party testing to improve efficiency, reduce costs and to ensure data validity and accuracy.
RJ Lee Group (RJLG) is an ISO 17025 certified, FDA-registered laboratory with established quality control and process control systems that are compliant with cGMP-level standards. Our experts work with clients to investigate their manufacturing processes from all levels of the products lifecycle. From the raw material stage to failure analysis on the finished product, RJLG develops validated protocols and uses them to provide scientific resolution. However, we provide more than just test results and simple conclusions; we focus on a complete characterization of the analytics behind the results. Not only are test procedures utilized to assess the data specific to each test, but an orthogonal approach is also employed to investigate the summary of results, in order to provide a more comprehensive evaluation of the study.
RJLG’s specialty is our variety of instrumentation and expertise. Many companies may have spectroscopic or chromatographic techniques, but we add to those offerings with our core characterization suite of analyses that includes SEM/EDS, FTIR, Raman and PLM. Our full-service chemistry department augments these services, providing GCMS, GC, ICP-AES, ICP-MS, IC, XRD, DSC, and TGA, along with Hi-resolution SEM/EDS, XPS surface analysis, and TEM analysis offered by our Advanced Materials group. The combined expertise we offer brings the puzzle pieces together for a complete material identification.
For more information on how our BioPharmaceuticals group can help your industry, please contact us at 1.800.866.1775, or click the button below.